Condition category
Musculoskeletal Diseases
Date applied
28/03/2015
Date assigned
16/06/2015
Last edited
12/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA), the most common type of arthritis, is a condition that causes joints to become painful and stiff. OA typically affects the knees, hips and small joints of the hands. OA is an incurable, long term condition but there are a number of treatments available to manage its symptoms, in addition to maintaining a healthy weight and regularly exercising. OA of the knee can often result in disability and make it hard for people to carry out their normal daily activities. It can also make it difficult for people to exercise. Physiotherapists can help people to create an exercise plan to manage their symptoms. They also provide various treatments to reduce pain and swelling in the joints. One such treatment is transcutaneous electrical nerve stimulation (TENS), which is often used to reduce pain in OA. In TENS, electrodes attached to a small, battery-operated machine are placed on the affected body part, such as the knee. When the machine is switched on, electrical signals are sent to the nerves which disrupt the pain signals. There are also various complementary and alternative therapies available to people with OA. Intrasound Therapy (IST) is a complementary therapy which uses sound waves to give pain relief for inflammatory conditions such as OA of the knee. It is a simple device for home use, and some OA sufferers have found that it helps relieve their symptoms. However, IST has not been scientifically tested so we don’t know how well it actually works. This is the first study to test how well IST works in adults with OA of the knee. The aim of this study is to see how well IST works to help patients with OA of the knee manage their pain compared to TENS.

Who can participate?
Adult with OA of the knee

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (control group) carry out a range of exercises. Those in group 2 (intervention group) receive IST and carry out a range of exercises. Those in group 3 (intervention group) receive TENS and carry out a range of exercises. Mobility and pain levels are measured before treatment and after 8 weeks of treatment. Participants also complete questionnaires.

What are the possible benefits and risks of participating?
Participants are not exposed to any known risks as the treatments are considered safe to use.

Where is the study run from?
Lagos University Teaching Hospital (Nigeria)

When is the study starting and how long is it expected to run for?
June 2014 to November 2014

Who is funding the study?
Investigator initiated and funded (Nigeria)

Who is the main contact?
Dr A Aiyegbusi (scientific)
aaiyegbusi@unilag.edu.ng

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ayoola Aiyegbusi

ORCID ID

http://orcid.org/0000-0002-8052-0908

Contact details

Department of Physiotherapy
College of Medicine
University of Lagos
Lagos
02341
Nigeria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intrasound therapy is an effective adjunct in the management of osteoarthritis of the knee: a preliminary clinical study

Acronym

Study hypothesis

Will intrasound therapy be as effective as TENS, a proven physiotherapy modality as an adjunct in the management of osteoarthritis of the knee?

Ethics approval

Health, Research and Ethics Committee of the Lagos University Teaching Hospital, Nigeria, 22/07/2014, ref: ADM/DCST/HREC/1806

Study design

Single-centre preliminary clinical interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Mild/moderate unilateral osteoarthritis of the knee

Intervention

1. Group 1 (control): closed kinetic chain exercises and range of motion exercises
2. Group 2 (intervention): intrasound therapy for 10 minutes followed by closed kinetic chain exercises and range of motion exercises
3. Group 3 (intervention): TENS for 15 minutes followed by closed kinetic chain exercises and range of motion exercises

Intervention type

Device

Phase

Drug names

Primary outcome measures

Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention: Western Ontario and McMaster Universities (WOMAC) score to assess pain, stiffness and physical function.

Secondary outcome measures

Assessed pre-treatment, at baseline and post-treatment after 8 weeks of intervention:
1. 6-minute walk test
2. Range of motion of the knee

Overall trial start date

04/06/2014

Overall trial end date

14/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 52-76
2. Unilateral OA of the knee

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Patients with underlying systemic diseases and other rheumatic conditions of the knee
2. Patients with severe OA using the Kellgren and Lawrence system of classification

Recruitment start date

29/07/2014

Recruitment end date

12/09/2014

Locations

Countries of recruitment

Nigeria

Trial participating centre

Lagos University Teaching Hospital
Department of physiotherapy
Lagos
Nigeria

Sponsor information

Organisation

Lagos University Teaching Hospital

Sponsor details

Health
Research & Ethics Committee
Idiaraba
Lagos
02341
Nigeria

Sponsor type

Hospital/treatment centre

Website

www.luthnigeria.org

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results to be disseminated through peer-reviewed scientific journals and presentation at scientific conferences

Intention to publish date

30/03/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes